Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

Phase 2

Completed

• Conditions: Schizophrenia; Mania

• Registration Number: NCT00102479
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted QC: 2005-01-28
• Study First Submitted: 2005-01-29
• Study First Posted: 2005-01-31
• Study Completion: 2005-07
• Status Verified: 2006-04
• Last Update Submitted: 2006-04-13
• Last Update Posted: 2006-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder

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Exclusion Criteria

• History of mental retardation
• Any neurological disorder with the exception of Pervasive Developmental Disorder (PDD), Attention Deficit Hyperactivity Disorder (ADHD), and Tourette's Syndrome

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified